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Re: north40000 post# 80323

Wednesday, 07/01/2009 6:35:47 PM

Wednesday, July 01, 2009 6:35:47 PM

Post# of 252493
Can someone translate the DSCO news to English??

I realize the stock is cooked, or burnt is a better word, and thank God I was not in it this time around. However, I am having trouble figuring out what they are saying when they say:

"Discovery Labs learned that the FDA will now apply a newly-defined standard to determine whether Discovery Labs has adequately demonstrated comparability of Surfaxin clinical to commercial drug product. This new standard represents a significant hurdle for approval of Surfaxin."

Does that mean that the FDA does not think that DSCO has demonstrated that the stuff used in the trial is the ssame stuff they are currently manufacturing? Or does it mean that their trials are not valid? Or what???

TIA

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